ridingthelight Posted - 53 minutes ago

$VERU now the excuse is "due to the holidays."

EsquireTradingCo Posted - 53 minutes ago

$VERU Was really hoping today was the day...hopefully next week.

Davedavedave Posted - 1 hour ago

$VERU added wt 5.75. average is now 6.8 😬

TaoistImmortal Posted - 2 hours ago

$VERU Timing is the reason for length of time. First, the Dec holidays; second, the new FDA guidlines as a result of Omnibus didn’t go in effect until the New Year, which, subsequently is when the venerable Dr. Ho showed up on the scene. Now… give the good, the awesome, the iconic Dr. Ho plenty of elbow room to work and design a kick ass confirmatory trial. Good composition, good design takes time and everyone is better off for it, even if some are nervously peeing their pants in the interim. As Charlton Michelangelo Heston said to the constant Pope badgering of ” but when will it be done?”, it will be done ” When it is done”. Sorry folks greatness can’t be rushed and and the great one is presenting to an institution that moves as fast as a battleship carrier turns around. And with newfound insight, or should I say, belief, and a delightfully insulting alliteration from Y, I know think it’s a matter of when not if….

YochananS Posted - 3 hours ago

$VERU As mentioned by many, there are a few problems with a confirmatory blinded trial: 1. If it wasn't ethical to continue ph3, how is it ethical to ask for another one? 2. If EUA given in parallel to this placebo controlled trial, why wpuld people agree to participaye if tgey can get the drug under ZEUA? The RWE/RWD approach solves both of these issues. Now tbe question is, why did they take 90 days to figure this out?

ridingthelight Posted - 4 hours ago

$VERU another business week in the books. this is a different week, as we ended the 1st month and started a new month, but with the same pattern as last year. no news of any value or positivity but lots of hype

YochananS Posted - 4 hours ago

$VERU Towie I think the argument you make, that if fda was convinced by adcom vote that Sab should be denied eua, they would have issued it a long time ago is very compeling. Apparently they werent convinced. But, Steiner was asked about the onfirmatory study desing in the last call and said it was ready going into adcom (I think), so that can't be it. However, the study he was refering to which fda described (see Steveten post) was a placebo controlled double blinded study, and we know there are many problems with that kind of study in this constelation. So, maybe the way out of this mess was really the RWE/RWD approach. This would mean they need to design a new study which might explain the delay. The one piece I'm missing, is why was fda not communicating this with Veru? In the last call it seemed apparent to me that Veru were left in the dark, based on Steiners note about fda checking their invisible boxes. Thoughts anyone?

zach12345 Posted - 4 hours ago

$VERU closed below 6 like I said it will so they killed the calls

Steveten Posted - 4 hours ago

$VERU This was supposed to be approved under EUA back in August. Everyone including VERU was surprised to see FDA requested ADCOM. They very same day FDA requested ADCOM Pfizer got a $4.5B contract extension for Paxlovid. The media did not report on it. AdCom was initially set for October and pushed back again to November. And now here we are. It's been a brutal 6 months.

mrkymrk Posted - 4 hours ago

$VERU At this stage in the process I’m always fearful of the Friday after hour PR dump. Will be holding my breath the next couple hours.

zach12345 Posted - 5 hours ago

$VERU wondering what’s going to happen to next week’s 6 call given the earnings report , they’re asking 0.60 for them

TaoistImmortal Posted - 5 hours ago

$VERU From the Texas Ape post: ”… we are still seeking emergency authorizations or their equivalent…” ” Or their equivalent” is not a hint, not “smoke signal”, not a “tea leaf” it is a flat out declaration from VERU. So ” equivalent” is the X factor which could again mean the design of a confirmatory trial per the new Omnibus/ FDA guidelines. And of course, Dr. Ho…

Steveten Posted - 5 hours ago

$VERU 90 Days ago the FDA in their briefing document suggested pursuing a placebo controlled trial. We've had discussions around the ethics of this type of trial. If common sense prevails FDA approves with RWE - a real world evidence based confirmatory trial where data is collected to measure safety and efficacy in place of placebo. The only other option is for Veru to pursue an NDA for ARDS in a phase 3 trial on a much larger scale to satisfy FDA. This would require a significant cash raise (via another offering) or an acquisition/partnership.

towie Posted - 5 hours ago

$VERU I’m curious to know what others think about this. Since the adcom meeting I’ve thought that if the FDA had been convinced by the adcom’s decision that it shouldn’t be approved then FDA would’ve already denied it. The only thing I can think of is that it’s discussing & finalizing the design of a new trial with Veru before it announces approval of the EUA. That’s the only thing that makes sense to me because it makes no sense to me that a decision against it should take three months if it had agreed with adcom. I am still nervous about the ultimate decision though

TommyBoy777 Posted - 6 hours ago

$VERU Funny how volume continues to climb but price sticks at $5.77 🤔 Tommy T. 😎

SNPNH Posted - 6 hours ago

$VERU I really thought that the FDA would announce approval this week. I now think they will announce next week that they requires another 30-60 days. The FDA is a corrupt inefficient ineffective bureaucratic agency that does not work in the best interests of patients. Very sad and disappointing. I do think approval is still coming eventually.

betonthenews Posted - 6 hours ago

$VERU @EsquireTradingCo The Feb 1st calls' volume of FEB $7 calls 1532, $7.5 calls 5627, FEB $10 calls 1609 are all bullish bets, 1400 Feb $7 calls and 5300 Feb $7.5 calls are new open interests now, and Feb 10 call open interests are down 1000 calls now which means the Feb 10 call sellers bought back 1K to close their books.

Texas_Ape Posted - 6 hours ago

$VERU In conclusion, fiscal year 2022 was a transformational year for Veru, and the positive Phase 3 results of sabizabulin for COVID-19 set the stage for potentially significant growth opportunities. To that end, we are focused on actively seeking emergency authorizations, or their equivalent, for sabizabulin on a global scale. Veru is committed to developing and commercializing drugs that have the potential to provide important mortality and morbidity benefits for patients with viral acute respiratory distress syndrome, as well as breast and prostate cancers. We look forward to the year ahead.

Texas_Ape Posted - 6 hours ago

$VERU In prostate cancer, we are actively enrolling the Phase 3 VERACITY registration study evaluating sabizabulin treatment for metastatic castration resistant prostate cancer, as well as the Phase 2 clinical dose finding trial of VERU-100, a long-acting GnRH antagonist 3-month depot formulation, for androgen deprivation therapy of advanced prostate cancer.

Texas_Ape Posted - 6 hours ago

$VERU In breast cancer we are actively recruiting patients in two Phase 3 registration trials of enobosarm, a selective androgen receptor targeting agonist. The trials are the Phase 3 ARTEST trial for the third line treatment of AR+ER+HER2- metastatic breast cancer, which was granted Fast Track designation by the FDA, and the Phase 3 ENABLAR-2 trial for the second line treatment of AR+ER+HER2- metastatic breast cancer in combination with abemaciclib, Eli Lilly’s CDK 4/6 inhibitor. Earlier this year, we entered into a collaboration and supply agreement with Eli Lilly for the ENABLAR-2 trial. We believe enobosarm has the potential to establish a new drug class of targeted endocrine therapy in advanced breast cancer patients that have become resistant to estrogen treatments.

Texas_Ape Posted - 6 hours ago

$VERU In preparation for potential emergency authorization in the U.S. and abroad, we scaled up sabizabulin manufacturing processes to meet a potential increase in commercial product demand. We also appointed key executives Joel Batten and Jason Davies to lead our infectious disease franchises in the U.S. and internationally, respectively. Both Mr. Batten and Mr. Davies bring extensive infectious disease management, sales, and marketing expertise from large pharmaceutical companies to Veru. Our clinical development strategy is focused on the expansion of our drug candidate pipeline into serious viral infections that cause acute respiratory distress syndrome and death. Specifically, following the positive Phase 3 trial of sabizabulin in COVID-19, we intend to initiate Phase 3 studies of sabizabulin treatment in influenza and Respiratory Syncytial Virus (RSV).

EsquireTradingCo Posted - 7 hours ago

$VERU No current authorizations for severe COVID...WE GOT THIS!!! https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs

zach12345 Posted - 7 hours ago

$VERU calls 6 expiring

zach12345 Posted - 7 hours ago

$VERU it’s going to close below 6

Steveten Posted - 7 hours ago

$VERU Great dips

Steveten Posted - 7 hours ago

$VERU It's FDA Friday's at the office.

Dooright Posted - 7 hours ago

$VERU Looks like I was wrong again and it will be the eleventh hour. Perhaps it will be? Good God already. 😖 Doc C. 🤓

cctranscripts Posted - 7 hours ago

The Law Offices of Frank R. Cruz Reminds Investors of Looming Deadline in the Class Action Lawsuit Against Veru Inc. (VERU) https://conferencecalltranscripts.com/summary/?id=495509&pr=true $VERU

EsquireTradingCo Posted - 7 hours ago

$VERU Just bought 200 $10 calls for 2/17. If 90 days means 90 days I'll at least get my answer before expiration.

mrkymrk Posted - 8 hours ago

$VERU VERU sales team is getting paid to repost Linked in messages for 8 months. Sounds like an easy enough job to me.